Chemotherapy Alone Versus Chemotherapy Plus Targeted Therapy as Adjuvant Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 主要终点
- relapse-free survival
研究概览
简要总结
Chemotharapy plus targeted therapy regimen, as an adjuvant therapy, can effectively reduce the rate of both intrahepatic and extrahepatic recurrence in initially unresectable CRLM patients. Those with KRAS/NRAS/BRAF mutated tumors or cycle of conversion therapy ≤ 4 can benefit more from chemotharapy plus targeted therapyrather than from chemotharapy alone, with a tolerable toxicity profile.
详细描述
This multi-center study enrolled consecutive patients with initially unresectable CRLM who underwent conversion therapy or radiofrequency ablation (RFA) and achieved no NED status between June 1, 2013, and June 30, 2020, from Zhongshan Hospital of Shanghai, Zhongshan Hospital of Xiamen, Cancer Hospital of Beijing. The inclusion criteria were as follows: (1) with histologically confirmed CRC; (2) with initially unresectable synchronous liver metastases (LMs); (3) accepted conversion therapy and successfully converted into resectable status; (4) underwent R0 intestinal and hepatic resection; (5) accepted adjuvant therapy. The exclusion criteria were as follows: (1) R1/R2 resection; (2) extrahepatic metastases; (3) accepted postoperative monotherapy; (4) lack of follow-up data. According to the adjuvant therapy regimen (with or without targeted therapy), the cohorts were divided into CA cohort and CT cohort. The study was approved by the ethics committee of three medical centers and was adhered to Good Clinical Practice guidelines and the Declaration of Helsinki. Written informed consent was obtained from all participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years;
- •Histologically confirmed CRC;
- •Initially unresectable synchronous liver metastases (LMs);
- •Accepted conversion therapy and successfully converted into resectable status;
- •Underwent R0 intestinal and hepatic resection;
- •Accepted adjuvant therapy.
排除标准
- •R1/R2 resection;
- •Extrahepatic metastases;
- •Accepted postoperative monotherapy;
- •Lack of follow-up data.
研究组 & 干预措施
Chemotherapy plus Targeted therapy (CT)
The treatment decisions and evaluation of treatment outcomes, such as the assessment of metastases resectability and tumor response, were carried out by the multi-disciplinary team (MDT) comprising experts from each medical centers. In this cohort, initially unresectable colorectal cancer liver metastasis (CRLM) patients who were successfully converted and achieved no evidence of disease status were treated with chemotherapy plus targeted therapy, as adjuvant therapy.
干预措施: Targeted agent (Drug)
结局指标
主要结局
relapse-free survival
时间窗: 3 years
The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death
次要结局
- overall survival(5 years)
研究者
Xu jianmin
Head of Colorectal Surgery
Fudan University
